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Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00383591
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Hepatitis B adjuvanted vaccine Biological: Engerix-B Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III, Clinical Trial Comparing the Persistence of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B at Months 24, 30, 36, in Pre-haemodialysis/Haemodialysis Patients (≥15 Years of Age)
Study Start Date : March 2002
Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Biological: Hepatitis B adjuvanted vaccine Biological: Engerix-B
    Other Name: Hepatitis B adjuvanted vaccine

Outcome Measures

Primary Outcome Measures :
  1. Anti-HBs seroprotection
  2. Response to booster

Secondary Outcome Measures :
  1. Solicited, unsolicited symptoms and serious adverse events

Eligibility Criteria

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects were to have completed primary vaccination course. A male or female > = 15 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject/ from the parents or guardians of the subject.
  • If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Pregnant or lactating female.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383591


Locations
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Malaysia
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 56000
Spain
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Malaga, Spain, 29010
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00383591     History of Changes
Other Study ID Numbers: 208129/047
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs